Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB (OPCAB)
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ClinicalTrials.gov Identifier: NCT00073593 |
Recruitment Status :
Completed
First Posted : November 27, 2003
Last Update Posted : November 10, 2011
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Condition or disease | Intervention/treatment | Phase |
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Cardiac Surgery Coronary Artery Bypass Surgery | Drug: Bivalirudin Drug: Heparin Drug: Protamine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | May 2004 |

Arm | Intervention/treatment |
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Experimental: bivalirudin
250mg vial given as 0.75mg/kg intravenous (IV) bolus and 1.75 mg/kg/hr IV infusion for the duration of the procedure with the option to increase or decrease the infusion in 0.25 mg/kg/hr increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an ACT>300 seconds.
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Drug: Bivalirudin
250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) >300 seconds (s). |
Active Comparator: heparin/protamine
1.5-3.5 mg/kg (200-400 U/kg) intravenous (IV) bolus to target an ACT >300 seconds followed by weight-adjusted boluses as needed during the procedure to achieve/maintain the target ACT. Protamine as needed
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Drug: Heparin
: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of >300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock. Drug: Protamine Per institutional practice. Batches from hospital stock. |
- Death [ Time Frame: Hospital discharge or Day 7 ]
- Q-wave MI [ Time Frame: hospital discharge or day 7, ]
- Repeat Coronary Revascularization, [ Time Frame: hospital discharge or day 7, ]
- Stroke (hemorrhagic or ischemic). [ Time Frame: hospital discharge or day 7 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion:
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age.
- Be accepted for elective off-pump coronary artery bypass graft (CABG) surgery without concomitant cardiac surgical procedures.
- < 4 planned Coronary Artery Bypass Grafts
Exclusion:
- Any prior Cardio-Thoracic Surgical procedures requiring median sternotomy
- Confirmed pregnancy - baseline urine or serum pregnancy test (if woman of childbearing potential).
- Cerebrovascular accident within 6 months before randomization, or any cerebrovascular accident with residual neurological deficit.
- Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Dependency on renal dialysis or creatinine clearance <30mL/min.
- Ongoing treatment with warfarin (or other oral anticoagulants) at the time of randomization. Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is <1.3 times control in the absence of heparin therapy.
- Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any component of these products.
- Patients receiving clopidogrel within the previous 5 days of randomization.
- Patients receiving a glycoprotein IIb/IIIa inhibitor within 48 hours if abciximab (ReoPro) or within 24 hours if eptifibatide (Integrilin) and tirofiban (Aggrastat) of randomization
- Patients receiving lepirudin or argatroban within the previous 24 hours of randomization.
- Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
- Patients with active or prior history of heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS)*.
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
- Refusal to undergo blood transfusion should it become necessary.
- Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial or inability to comply with study requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073593
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 |
Study Director: | Andrew Sternlicht, MD | The Medicines Company |
Responsible Party: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00073593 |
Other Study ID Numbers: |
TMC-BIV-02-07 EVOLUTION |
First Posted: | November 27, 2003 Key Record Dates |
Last Update Posted: | November 10, 2011 |
Last Verified: | November 2011 |
Off-Pump Coronary Artery Bypass Graft Surgery CABG OPCAB Heparin Patients requiring off-pump CABG |
Heparin Bivalirudin Protamines Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Heparin Antagonists Coagulants |